The aim of this study is to assess the efficacy and safety of lixisenatide for treating type 2 diabetes. A systematic search in electronic databases (up to October 2012) was conducted and the manufacturer was contacted regarding unpublished data. Randomized controlled trials (RCTs) were included if they provided information on at least one of the following outcomes: mortality, health-related quality of life, hypoglycaemic events, adverse events, change in HbA1c, body weight, blood pressure, gastric emptying, fasting plasma glucose or 2 h postprandial glucose (PPG). Twenty-six publications and 10 unpublished study reports, relating to 14 RCTs (6156 patients) were included. Eleven studies related to placebo comparisons; active comparators were in three studies. Compared to placebo, lixisenatide significantly reduced HbA1c (-0.52%; 95% CI: -0.64 to -0.39), bodyweight (-0.65 kg; 95% CI: -0.94 to -0.37) and 2-h PPG level (-4.58 mmol/l; 95% CI: -5.88 to -3.28). There were significantly more symptomatic hypoglycaemic events among lixisenatide compared to placebo-treated patients (log OR: 0.54; 95% CI: 0.32-0.75), but significantly fewer compared to other incretin mimetics. In comparison to exenatide and liraglutide, lixisenatide was more effective in reducing 2 h-PPG with a better adverse events profile, but it showed a lower reduction in HbA1c and body weight. Lixisenatide improves HbA1c levels and moderately reduces body weight compared to placebo and showed less frequent symptomatic hypoglycaemic and gastrointestinal events and an improvement in PPG control compared to other GLP-1 agonists. Firm conclusions regarding the performance of lixisenatide compared to other incretin mimetics, however, can not yet be drawn, due to limited data.
Keywords: GLP-1 receptor agonists; lixisenatide; meta-analyses; systematic review; type 2 diabetes mellitus.
© 2014 John Wiley & Sons Ltd.